|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P980035 S073/ PAS001 |
| Date Original Protocol Accepted |
05/13/2008
|
| Date Current Protocol Accepted |
05/13/2008
|
| Study Name |
Longterm Study PAS
|
| Device Name |
MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a 5-year, prospective, non-randomized, multi-center parallel study of implanted nEw3 (Adapta /Sensia/Versa) devices using a historical comparison group. Subjects will be compared against the U.S. market released Adapta /Sensia/Versa IPGs historical control group consisting of Medtronic registered devices as reported in the Medtronic Cardiac Rhythm Disease Management Product Performance Report
|
| Study Population |
Study Population: All enrolled subjects have been implanted with a nEw3 device. Indication: The indications include: 1) rate adaptive pacing in patients who may benefit from increased pacing rates
concurrent with increases in activity, 2) accepted patient conditions warranting chronic cardiac pacing, 3) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders, 4) the Medtronic AT500 system is also indicated for dual chamber and atrial tracking
modes in patients who may benefit from maintenance of AV synchrony.
|
| Sample Size |
At least 222 patients to ensure that at least 200 subjects are followed for 5 years, it is estimated that approximately 336 subjects will need to be enrolled, 72 sites
|
| Key Study Endpoints |
Medtronic CRDM considers a device as having malfunctioned whenever the analysis shows that any parameter was outside the performance limits established by Medtronic while implanted and in service. To be considered a malfunction, the device must have been returned to Medtronic and analyzed as a confirmed device malfunction. All subjects in the SLS study with a nEw3 device will be included until the cohort for analysis is met. Any nEw3 devices returned to Medtronic through returned product and found to have malfunctioned within 6 months after implant will also be included in the analysis. Devices damaged after explant, damaged due to failure to heed warnings or contraindications in the labeling, or damaged due to interaction with other implanted devices (including leads) are not considered device malfunctions.
|
| Follow-up Visits and Length of Follow-up |
All subjects who are included in the analysis of the primary objective will continue to be followed for a total of 5 years post-implant. The follow-up schedule for this study is based on utilizing routine, scheduled office/clinic visits and unscheduled office/clinic visits prompted by symptoms or complaints. Follow-up office/clinic visits post-implant are suggested to be at least annually for subjects with an IPG, and a minimum of one follow-up visit every 24 months.
|
| Interim or Final Data Summary |
| Interim Results |
There were 18 deaths reported which represents 2.4% of the subjects enrolled. No deaths were deemed as system related. Two deaths were reported with unknown causes. To be considered a malfunction, the device must have been returned to Medtronic for analysis. Currently, 7 of 11 failure devices were returned. Six of the returned devices found "no anomolies" and one device revealed misshapen multi beam connectors after microscopic visual analysis of the atrial connector block.
|
| Actual Number of Patients Enrolled |
2927
|
| Actual Number of Sites Enrolled |
132
|
| Patient Follow-up Rate |
75.23%
|
| Final Safety Findings |
The 5-year device survival probability was 100.0%, with 95% CI (99.7%, 100.0%).
|
| Final Effect Findings |
N/A
|
| Study Strengths & Weaknesses |
1) large sample size of 2927 subjects
2) long-term follow-up for 5 years
Weakness: 1) study deviation rate of 12.16% per visit
|
| Recommendations for Labeling Changes |
No
|
